NCT01862601已完成1 期
Study to Evaluate the Safety and Performance of the JetTouch Needle-Free Endoscopic Injection System to Deliver Saline Into the Bladder Wall of Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety of the JetTouch system to deliver saline into the bladder wall.
研究概览
简要总结
This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. It is hoped that this method will provide a reliable and consistent method to deliver drugs into the bladder wall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.
排除标准
- •Unable or unwilling to sign Informed Consent Form or comply with study requirements
- •Non-English speaking
- •Currently enrolled in another clinical trial
- •Undergone treatments given into the bladder in the past 4 weeks
- •Female subject and has a positive urine pregnancy test at the time of screening/procedure or intends to become pregnant while enrolled
- •Female subject and is currently breast feeding
- •Female subject and has given birth in past 6 months
- •Current or history of chronic urinary tract infections
- •Current or history of chronic hematuria
- •Current or history of bladder cancer
- •History of major surgery in the last 6 months
- •Current or history of bleeding disorders
- •Currently taking anticoagulants
- •Taking aspirin and is unable to discontinue treatment for 2 weeks prior to bladder injection
- •Taking NSAIDS and is unable to discontinue 48 hours prior to bladder injection
- •Platelet count, prothrombin time/INR (PT/INR) and partial thromboplastin time (PTT) outside the normal limits of the laboratories established reference ranges
- •Current or history of any of the following: neurogenic bladder, radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi
- •Known hypersensitivity to any of the agents used in the injection (FLEXLINE-Bladder® Attachment material, lidocaine, saline, Indigo Carmine dye or Ciprofloxacin)
- •Current or history of any medical condition that in the opinion of the Investigator would make them an unsuitable candidate for this study.
研究组 & 干预措施
JetTouch injections
Experimental
干预措施: JetTouch Needle-free injection system (Device)
结局指标
主要结局
Safety of the JetTouch system to deliver saline into the bladder wall.
时间窗: within 14 days of the JetTouch procedure
Ability of the JetTouch system to deliver saline into the bladder wall.
时间窗: At the JetTouch procedure
次要结局
- Physician feedback on the use of the JetTouch system.(At the JetTouch Procedure)
- Physician feedback on perceived subject tolerability of the JetTouch injection procedure.(At the JetTouch procedure.)
- Subject feedback question regarding the procedure.(At the JetTouch procedure)
研究者
研究点 (2)
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